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FDA recall Z-1479-2024 lists device identifier 00380740001414 and lot 59194BE00, with a correction notice dated March 4, 2024. A separate MAUDE report, 3002809144-2024-00184, names the same identifier and lot, with an event date of May 23, 2024: 80 calendar days later.
The report describes a false-reactive hepatitis C test after a syphilis test. Its manufacturer narrative discusses reagent carryover and a revised assay file adding a wash step. It records no impact to patient management.
This connection is specific enough to investigate correction follow-through, not to conclude that a fix failed. The missing evidence is the affected instrument's update and calibration history. Both original documents were reviewed for this comparison.
Recorded evidence
Limitations & review notes
- Research draft. Conclusions may change; review the sources and limitations before relying on them.
- Restored archival research draft: not independently reverified for this republication and not actively monitored. Check the linked originals and dated scope before relying on it.
- The report does not establish whether the revised assay file was installed before the event; a post-notice event is not proof of post-fix failure.
- MAUDE contains reported events and manufacturer narratives, not independent causal adjudications. This report says there was no impact to patient management.
- One matched report cannot establish incidence, the number of affected patients, or the effectiveness of the correction across laboratories.
- Novelty is the reviewed identifier-and-date connection, not a claim of first-ever discovery. A targeted web search found the underlying records but did not establish whether someone else has already made this connection.